Ethylenediamine, ethoxylated and propoxylated

Endpoint summary

Additional information

Three in vitro mutagenicity studies were all negative with the registered substance. In addition, bacterial Ames assay with the similar substance, EDA/PO was used to fully satisfy the information requirement of Annex VII, 8.4.1 for EDA/EO/PO. These in vitro assays were: i) Bacterial Reverse Mutation Assays (OEDC 471), ii) Chromosome Aberration Test (OECD 473), and iii) Mammalian Cell Gene Mutation Test (OECD 476). No further testing is required as the registered substance was non-genotoxic in these in vitro tests and, hence, not classified for this endpoint.

Rationale for Category Grouping:

The full justification document for EDA-initiated NLP alkoxylate category grouping has been prepared and is attached separately in Chapter 13. See also Illing and Barratt (2007 revised 2009) attached in Chapter 13.

In the REACH registration dossier for EDA/EO/PO, the information requirement for testing in five bacterial strains in an in vitro gene mutation study in bacteria (Annex VII, 8.4.1, test method: EU B.13/14 / OECD 471) is addressed using Ames data from EDA/PO test, all other available genotoxicity assays including negative Ames assay with EDA/EO/PO, structural features of the substances in the category, and the read-across for the category in line with Annex XI. More supporting information for the read-across can be found in EDA/PO Ames record summary. The results of all genotoxicity assays with the category members were negative. In addition, both category substances exhibit low acute toxicity, similar irritancy and skin sensitisation behaviours across the range of molecular weights.

The EDA-initiated NLP alkoxylate category grouping is based on structural similarity, common functional groups, common breakdown products, and similar physicochemical and toxicological properties. This category contains two NLP Polyols that are based on the core EDA initiator alkoxylated with either PO only (EDA/PO), or PO with smaller % of EO monomers (EDA/EO/PO). 

The UVCB category substances are prepared via similar manufacturing process where the initiating core substance, ethylenediamine (EDA), is reacted with structurally similar monomers. The linkage between the core initiator and the monomers is through the amine group and ether linkage connects the individual monomers. This group of substances exhibit similar toxicokinetic properties due to structural similarity and similar physicochemical properties. Both substances are thought to be absorbed by passive diffusion. The category members are expected to have common breakdown product, the propylene glycol repeat unit.

At or above 280 g/mol MW, the category members are expected to have at least four alkoxylate glycol repeat units as the major species and both amines of the core substance will be tertiary due to preferential reactivity of monomers with amine groups compared to terminal hydroxyl groups. The EDA/EO/PO Voranol RA 800 product is tested for free amines as part of specification; no free amines are present in the product. Increases in molecular weights would correspond with the increased average number of alkoxylate moieties per molecule, with the amines of EDA core also being tertiary. Tertiary amines have low reactivity towards macromolecules, including DNA.

Short description of key information:
Bacterial reverse mutation assays (OECD 471): negative
Chromosome Aberration test (OECD 473): negative
In vitro Mammalian Cell Gene Mutation test (OECD 476): negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The results from in-vitro testing of genetic toxicity do not warrant classification according to EU GHS.